Diagnostica Stago, Inc.: Device Recall
Recall #Z-1993-2025 · 05/21/2025
Recall Details
- Recall Number
- Z-1993-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Diagnostica Stago, Inc.
- Status
- Ongoing
- Date Initiated
- 05/21/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 939 US ( 2,810 total worldwide)
Reason for Recall
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Product Description
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Distribution Pattern
The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
Other Recalls by Diagnostica Stago, Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 09/12/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025